Local Hyperthermia for the Treatment of Cervical Persistent High-risk Infection

NCT07059819 | Enrolling By Invitation

• 1 other identifier: HH20241031
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Human papillomavirus(HPV) infect epithelial cells and have the capacity to stimulate cell abnormal hyperplasia, especially by those high-risk HPV types. HPV vaccine primarily targeting HPV6/11/16/18 has been available and makes it possible to prevent cervical cancer. However, a large population was left unvaccinated, specifically for those aged ones. In clinic, patients harboring high-risk HPV is quite prevalent in China or other developing nations. Removing the virus and prevention of malignant transformation is required. Mild local Hyperthermia with a certain temperature range has been successfully used in the treatment of some diseases. It has been utilized in the treatment of some neoplasm, fungal and HPV infections. Investigators' study found that local hyperthermia at 44°C could cleared HPV in more than half of the patients with HR-HPV in cervical area. So the purpose of the study is to evaluate the effective of local hyperthermia in the treatment of cervical intraepithelial neoplasias grade I and II after 3 months. Appropriate control arms were designed for different conditions.

Conditions

Cervical Intraepithelial Neoplasia (CIN); Human Papillovirus

Outcome Measures

Primary Outcomes (1)

• Clearance of high-risk HPV

  Detection of HPV genotype by PCR (21 subtypes)

  3 and 6 months after treatment

Study Arms (2)

Local Hyperthermia

EXPERIMENTAL

Device: Local hyperthermia device

Placebo

PLACEBO COMPARATOR

Device: Local hyperthermia device

Interventions

Local hyperthermia device DEVICE

Local hyperthermia at 44℃ for 30 mins on cervical region, at days of 1,2,3 and 17, 18.

Local Hyperthermia; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old; generally healthy gynecological conditions, normal sexual life; high risk HPV for persistent at least 3 months; Cervical biopsy CIN or no cytological changes; signed informed consent

You may not qualify if:

• Pregnant woman; local or systematic treatment within 3 months; Comorbidity of other severe gynecological inflammation, infection, or tumor; Comorbidity of other serious illnesses; no guarantee of timely treatment and follow-up.

Sponsors & Collaborators

• First Hospital of China Medical University: lead

Study Sites (1)

the First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: July 11, 2025
• Study Start: November 2, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 13, 2025

Record last verified: 2024-10

Locations

CN (1)